Gur­net Point-backed Au­re­gen taps Am­gen vet to lead; Ex-Roche RNA chief takes CEO post at Genevant

Gur­net Point Cap­i­tal-backed Au­re­gen Bio­Ther­a­peu­tics has tapped Am­gen vet Richard Davies to lead its rare dis­ease cell ther­a­py’s en­try in­to the clin­ic as CEO. Davies, a for­mer Hos­pi­ra chief com­mer­cial of­fi­cer who had his first chief ex­ec­u­tive ex­pe­ri­ence re­cent­ly at Bone­sup­port, will lead the dri­ve in trans­lat­ing the Gene­va-based biotech’s 3D bio­fab­ri­ca­tion tech­nolo­gies to new ther­a­peu­tics, start­ing from a pro­gram in rare con­gen­i­tal cran­io­fa­cial dis­or­ders.

→ Brick­ell Biotech has hired in­dus­try vet­er­an and Lil­ly $LLY Chief Mar­ket­ing Of­fi­cer Robert Brown to take the reins at the der­ma­tol­ogy com­pa­ny as it preps a late-stage tri­al eval­u­at­ing its drug, sof­piro­ni­um bro­mide, in pa­tients with ex­ces­sive un­der­arm sweat­ing in the first half of 2019. Brown, who has spent over three decades at Lil­ly, is set to re­place Brick­ell’s cur­rent CEO and co-founder Regi­nald Hardy on Jan­u­ary 1.

Bo Rode Hansen is step­ping up from a CSO po­si­tion to take the top job at Genevant. Un­like the rest of Vivek Ra­maswamy’s biotech fam­i­ly, the com­pa­ny is not in-li­cens­ing late-stage pro­grams, but build­ing a pipeline from scratch us­ing Ar­bu­tus’ RNA tech, with the aim of de­liv­er­ing more than five in-house and part­nered can­di­dates for clin­i­cal de­vel­op­ment by 2020. Hansen, the for­mer glob­al head of RNA at Roche with 50 dis­cov­ery pro­grams un­der his belt, will play a lead­ing role along­side a sea­soned ex­ec team.

→ A year af­ter Mary Szela left the helm of Nov­e­l­ion Ther­a­peu­tics $NVLN, the rare dis­ease biotech is shak­ing up its CEO of­fice again. Jef­frey Hack­man, the for­mer COO who’s been fill­ing in, has re­signed as in­ter­im CEO, pass­ing the re­spon­si­bil­i­ties to gen­er­al coun­sel Ben­jamin Harsh­barg­er. Hav­ing helped se­cure a re­cent loan fa­cil­i­ty, Harsh­barg­er is charged with the grand turn­around mis­sion by first fix­ing the cap­i­tal struc­ture.

→ Al­most a year af­ter step­ping down from Syn­er­gy Phar­ma­ceu­ti­cals — a com­pa­ny he found­ed and co-in­vent­ed the lead drug for — Gary Ja­cob has land­ed at a mi­cro­bio­me biotech in Aus­tralia. As CEO, Ja­cob is ex­pect­ed to chan­nel both his de­vel­op­ment, fi­nan­cial and com­mer­cial ex­per­tise in steer­ing Im­muron’s $IM­RN pipeline of oral­ly de­liv­ered poly­clon­al an­ti­bod­ies, which is led by a pro­gram for liv­er dis­eases.

→ Fol­low­ing a wide-rang­ing ca­reer fea­tur­ing stints at No­var­tis, L’Ore­al and SBM Man­age­ment Ser­vices, Stephan Jack­man has been ap­point­ed CEO of Alza­mend Neu­ro, a biotech de­vel­op­ing a cou­ple of Alzheimer’s drug can­di­dates out of the Uni­ver­si­ty of South Flori­da. Pri­or to the new role, Jack­man was fo­cused on ad­vanc­ing cures for mos­qui­to borne in­fec­tious dis­eases as COO of En­naid Ther­a­peu­tics.

→ New­ly pub­lic Ma­gen­ta Ther­a­peu­tics $MG­TA has scooped Ja­son Ryan from Foun­da­tion Med­i­cine to be its chief op­er­at­ing and fi­nan­cial of­fi­cer. The high fly­ing Cam­bridge start­up, which has a port­fo­lio fo­cused on bone mar­row trans­plant, can ben­e­fit from Ryan’s ex­pe­ri­ence in cap­i­tal cre­ation and al­lo­ca­tion as well as com­mer­cial plan­ning, says CEO Ja­son Gard­ner, as demon­strat­ed in his ef­forts with Foun­da­tion’s re­cent sale to Roche.  

→ Gothen­burg, Swe­den-based Iso­fol has hired Roger Tell — a bio­phar­ma vet who’s al­so run mul­ti­ple tri­als as a prin­ci­pal in­ves­ti­ga­tor — to run its clin­i­cal pro­gram as it ad­vances its lead prod­uct can­di­date in­to Phase III. Ar­foli­tixorin, de­vel­oped through a part­ner­ship with Mer­ck KGaA, is de­signed to boost the ef­fects of chemother­a­py main­ly in col­orec­tal can­cer. As CSO and SVP of clin­i­cal de­vel­op­ment, Tell will al­so over­see  sci­en­tif­ic re­search and tech­ni­cal op­er­a­tions.

→ With its Phase III pro­grams well un­der­way, Apel­lis Phar­ma­ceu­ti­cals $APLS has tapped Adam Townsend to plot a mar­ket­ing plan for APL-2 — its com­ple­ment C3 in­hibitor look­ing to ri­val Soliris in parox­ys­mal noc­tur­nal he­mo­glo­bin­uria — and al­so build a fran­chise in ge­o­graph­ic at­ro­phy, an ad­vanced form of age-re­lat­ed mac­u­lar de­gen­er­a­tion. The new chief com­mer­cial joins from Bio­gen, where he helped lead the launch­es of Tec­fidera and Spin­raza.

→ Fol­low­ing an 11-year ca­reer run­ning clin­i­cal op­er­a­tions for mul­ti­ple units — in­clud­ing the oph­thalmic fran­chise — at No­var­tis, Fabio Baschiera is jump­ing to an oph­thal­mol­o­gy start­up backed by the phar­ma gi­ant. His new ti­tle at Oculis will be VP of clin­i­cal de­vel­op­ment. Al­so join­ing the Swiss biotech: Louie-Anne Gau­thi­er, who will now scout deals for Oculis’ eye drop al­ter­na­tives for in­jectable drugs as its VP of strate­gic mar­ket­ing, busi­ness de­vel­op­ment and li­cens­ing.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.